The goal of the Annual Biosimilars Forum

In cooperation with our prestigious international scientific institute partners (the Viennese Section of the IBS and the Hungarian Society for Clinical Biostatistics), Accelsiors CRO launched the Annual Biosimilars Forum professional event series in order to provide even more effective support in sharing of recent scientific and practical knowledge for professionals who are working in and for biosimilar drug development.
We provide an opportunity for a constructive and open dialogue between regulatory professionals, clinical researchers, medical scientists, statisticians and pharmaceutical developers.

SOME INTERNATIONAL BIOSIMILAR EXPERT SPEAKERS FROM OUR PREVIOUS FORUMS

Shein-Chung CHOW
Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine

László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists

János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Professor at University of Miskolc, Dep. of Nanobiotechnology and the Regenerative Medicine, Institute of Theoretical Medicine

Andrea LASLOP
European Regulatory Expert,
Unit Head,
Austrian Medicines and Medical Devices Agency

Bernd JILMA
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna

Helmut SCHÜTZ
Owner at
BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies

SOME PROFESSIONAL LECTURES FROM THE PROGRAMS OF THE EVENTS

At the very successful Annual Biosimilars Forum event series clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this actual topic of research in lectures and informal discussions. Some topics of the last two year’s forums:

2nd Annual Biosimilars Forum – OCTOBER, 2017

Lecture examples:

• Scientific factors in biosimilar product development
László ENDRÉNYI, Professor Emeritus of University of Toronto;

• Open issues in the assessment of bioequivalence and biosimilarity
Helmut Schütz, Owner at BEBAC – Consultancy Services

• Regulatory Keynote lecture: 12 years of biosimilars in Europe
Andrea LASLOP, Unit Head, Austrian Medicines and Medical Devices Agency

• Immune side effects of biologicals and nanomedicines
János SZEBENI, Director of the Nanomedicine Research and Education Center

1st Annual Biosimilars Forum – OCTOBER, 2016

Lecture examples:

Shein-Chung_Chow• Design and analysis of biosimilar studies (3-part course)
Shein-Chung CHOW, Professor, Duke University School of Medicine

• Interchangeability of biological drug products
László ENDRÉNYI, Professor Emeritus, University of Toronto and László TÓTHFALUSI, Associate Professor, Semmelweis University of Budapest

Andrea LASLOP• The regulator’s view on the totality of evidence for biosimilar
Andrea LASLOP, Unit Head, Austrian Medicines and Medical Devices Agency

• Biosimilar development – a statistical assessor’s perspective
Stephan LEHR, Biostatistician, Austrian Medicines and Medical Devices Agency, President, Viennese Section of IBS

Please watch this short videos with the key lecturers and the organizers of the previous forums summarizing their thoughts about the topic and sharing their experiences or click on the next buttons to reach more information about the events with photo gallery, video interviews with the key lecturers and account of experiences articles of the events.

ASK OUR BIOSIMILAR RESEARCH EXPERTS!

Take advantage from the expertise and experience of Accelsiors’ biosimilar team. Combining our proficiency in different therapeutic areas, with tailored service capabilities and fast access to diverse patient populations, Accelsiors can support you in every aspect of clinical and nonclinical development of your biosimilar compound from the concept through pre-clinical development to successful conduct of Phase III registration trials. Ask Accelsiors’ experts and benefit from our expertise in biosimilars!

Some of Accelsiors - The scientific driven CRO‘ values provided for your success:

2 decades of experiences in biosimilar clinical trials

World-class
biosimilar knowledge base

Dedicated team of biosimilar
experts

Time- and cost efficient solutions to accelerate your program

Global resources
with a flexible local support

Complete range
of expertise tailored for your specific needs

DO YOU NEED MORE PROFESSIONAL HELP?

Feel free to ask Accelsiors - The scientific driven CRO‘ Biosimilar Reserach experts!

Focus with us on actual challenges of bio- and nanosimilar development on OCT, 2018 again!


Based on the success of our last year’s professional events, we started to prepare our next, 3rd Annual Biosimilars Forum, planned to be held in OCTOBER, 2018 in Budapest. This unique forum will cover important issues again and specific areas of debate facing clinical development teams biosimilars with a strong scientific focus on statistical and regulatory perspectives. The program of the event will be supported and complemented by international subject experts from the biosimilars and nanosimilars area.
It is particularly useful for those who are interested in constructive and open dialogue between medical statisticians, regulatory professionals, clinical researchers and sponsors with whom they collaborate.

ABOUT THE ORGANIZERS

The Annual Biosimilars Forum event series was founded in 2016 by two prestigious Central European scientific societies, the Viennese Section of the IBS and the Hungarian Society for Clinical Biostatistics in cooperation with the Accelsiors CRO Ltd., aimed at increasing effectiveness of clinical research and in order to provide even more effective support in sharing of recent scientific and practical knowledge for biosimilar development professionals and provide an opportunity for a constructive and open dialogue between regulatory professionals, clinical researchers, medical statisticians and pharmaceutical developers.

Viennese Section of the International Biometric Society
The Viennese Section of the International Biometric Society is part of the ROeS, the Austrian Swiss Region of the International Biometric Society (IBS). WBS is an independent, non-profit organization which provides a professional forum for discussions on how to apply statistical methods in biological and medical science.

Hungarian Society for Clinical Biostatistics
The Hungarian Society for Clinical Biostatistics is a national group of the International Society for Clinical Biostatistics (ISCB). One of its aims is to stimulate research of principles and methodologies used in the design and analysis of clinical trial.

Acccelsiors CRO Ltd.
Accelsiors – as a scientific driven CRO – has been a committed supporter of biosimilar drug development, many of their professionals were involved into biosimilar drug development from the early beginnings, guided and managed the first biosimilar drug development projects and professionally supporting clinical trials as well as registration in this innovative field and being active in the clinical research arena in the past two decades.